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Zhonghong Guan - One of the best experts on this subject based on the ideXlab platform.
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tolterodine extended release with or without Tamsulosin in men with lower urinary tract symptoms including overactive bladder symptoms effects of prostate size
European Urology, 2009Co-Authors: Claus G Roehrborn, Steven A Kaplan, Stephen J Jones, Joseph T Wang, Tamara Bavendam, Zhonghong GuanAbstract:Abstract Background Some men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms may benefit from antimuscarinic therapy, with or without an α-adrenergic antagonist. Objectives To evaluate the safety and efficacy of tolterodine extended release (ER), Tamsulosin, or tolterodine ER+Tamsulosin in men meeting symptom entry criteria for OAB and prostatic enlargement trials, stratified by prostate size. Design, setting, and participants Subjects with an International Prostate Symptom Score (IPSS) ≥12; frequency and urgency, with or without urgency urinary incontinence; postvoid residual volume (PVR) max ) >5mL/s were randomized to receive placebo, tolterodine ER (4mg), Tamsulosin (0.4mg), or tolterodine ER+Tamsulosin for 12 wk. Data were stratified by median baseline prostate volume ( Measurements Endpoints included week 12 changes in bladder diary variables, IPSS scores, and safety variables. Results and limitations Among men with larger prostates, tolterodine ER+Tamsulosin significantly improved frequency ( p =0.001); urgency ( p =0.006); and IPSS total ( p =0.001), storage ( p p p =0.030). Among men with smaller prostates, tolterodine ER significantly improved frequency ( p =0.016), UUI episodes ( p =0.036), and IPSS storage scores ( p =0.005). Tolterodine ER+Tamsulosin significantly improved frequency ( p =0.001) and IPSS storage scores ( p =0.018). Tamsulosin significantly improved nocturnal frequency ( p =0.038) and IPSS voiding ( p =0.036) and total scores ( p =0.044). There were no clinically or statistically significant changes in Q max or PVR; incidence of acute urinary retention (AUR) was low in all groups (≤2%). Conclusions Men with smaller prostates and moderate-to-severe LUTS including OAB symptoms benefited from tolterodine ER. Therapy with tolterodine ER+Tamsulosin was effective regardless of prostate size. Tolterodine ER, with or without Tamsulosin, was well tolerated and not associated with increased incidence of AUR.
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effects of serum psa on efficacy of tolterodine extended release with or without Tamsulosin in men with luts including oab
Urology, 2008Co-Authors: Claus G Roehrborn, Stephen R Kraus, Steven A Kaplan, Joseph T Wang, Tamara Bavendam, Zhonghong GuanAbstract:Objectives To evaluate the efficacy of tolterodine extended release (ER), Tamsulosin, and tolterodine ER plus Tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen (PSA) level. Methods We performed a post hoc analysis of data from men ≥40 years old with frequency and urgency (with or without urge urinary incontinence), postvoid residual urine volume 5 mL/s, International Prostate Symptom Score (IPSS) of ≥12, and quality-of-life score of ≥3. They had been randomized to placebo, tolterodine ER (4 mg), Tamsulosin (0.4 mg), or tolterodine ER plus Tamsulosin for 12 weeks. The men were stratified by the median baseline PSA level (≥1.3 vs Results The PSA level correlated significantly with prostate size. Men with a PSA level of ≥1.3 ng/mL receiving tolterodine ER plus Tamsulosin showed significantly greater improvements in 24-hour frequency, daytime frequency, the frequency-urgency sum, total IPSS, and IPSS storage score compared with those receiving placebo. Tamsulosin significantly improved the IPSS voiding scores, but tolterodine ER was ineffective. In men with a PSA level Conclusions The results of our study have shown that tolterodine ER was efficacious in men with lower urinary tract symptoms, including overactive bladder, who had lower PSA levels (
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extended release tolterodine with or without Tamsulosin in men with lower urinary tract symptoms and overactive bladder effects on urinary symptoms assessed by the international prostate symptom score
BJUI, 2008Co-Authors: Steven A Kaplan, Claus G Roehrborn, Tamara Bavendam, Martin Carlsson, Michael B Chancellor, Zhonghong GuanAbstract:OBJECTIVE To evaluate the efficacy of tolterodine extended-release (ER) plus Tamsulosin on lower urinary tract symptoms (LUTS) as assessed by changes in the International Prostate Symptom Score (IPSS) in men who met symptom entry criteria for both overactive bladder (OAB) and benign prostatic hyperplasia (BPH) trials. PATIENTS AND METHODS Men aged ≥40 years with an IPSS of ≥12 and diary-documented OAB symptoms (≥8 voids/24 h and ≥3 urgency episodes/24 h, with or without urgency urinary incontinence) who reported at least moderate problems related to their bladder condition were randomized to receive placebo, tolterodine ER (4 mg), Tamsulosin (0.4 mg), or tolterodine ER (4 mg) + Tamsulosin (0.4 mg) once daily for 12 weeks. Patients completed the IPSS at baseline and at 1, 6 and 12 weeks. RESULTS Patients receiving tolterodine ER + Tamsulosin had significantly greater improvements than those taking placebo on IPSS storage subscale scores and scores for all three individual storage items included on the IPSS (urinary frequency, urgency, and nocturnal micturitions) by 12 weeks. Storage subscale and urgency scores were significantly improved vs placebo at 1 and 6 weeks, whereas frequency scores were significantly improved at 6 weeks. Changes in IPSS storage subscale and individual storage item scores in the tolterodine ER and Tamsulosin monotherapy groups were not significantly different from placebo at most time points. IPSS voiding subscale scores and scores for three of four individual voiding items (sensation of incomplete emptying, intermittency, and weak stream) were significantly improved by 12 weeks for patients receiving Tamsulosin monotherapy vs placebo. Voiding subscale and intermittency scores were significantly improved vs placebo at 1 week; weak stream scores were significantly improved at 1 and 6 weeks. The IPSS voiding subscale and individual voiding item scores in the tolterodine ER + Tamsulosin and tolterodine ER groups were not significantly different from placebo at most time points. CONCLUSIONS In this distinct clinical research population of men who met traditional symptom entry criteria for both OAB and BPH trials, tolterodine ER + Tamsulosin was significantly more effective than placebo in treating storage LUTS, including OAB symptoms. Tamsulosin monotherapy produced significant improvements in voiding LUTS.
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tolterodine and Tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder a randomized controlled trial
JAMA, 2006Co-Authors: Claus G Roehrborn, Steven A Kaplan, Tamara Bavendam, Eric S Rovner, Martin Carlsson, Zhonghong GuanAbstract:ContextMen with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or α-receptor antagonists.ObjectiveTo evaluate the efficacy and safety of tolterodine extended release (ER), Tamsulosin, or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia.Design, Setting, and ParticipantsRandomized, double-blind, placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and, an International Prostate Symptom Score quality-of-life (QOL) item score of 3 or higher, a self-rated bladder condition of at least moderate bother, and a bladder diary documenting micturition frequency (≥8 micturitions per 24 hours) and urgency (≥3 episodes per 24 hours), with or without urgency urinary incontinence. Patients were recruited between November 2004 and February 2006, and the study was completed May 2006.InterventionsPatients were randomly assigned to receive placebo (n = 222), 4 mg of tolterodine ER (n = 217), 0.4 mg of Tamsulosin (n = 215), or both tolterodine ER plus Tamsulosin (n = 225) for 12 weeks.Main Outcome MeasuresPatient perception of treatment benefit, bladder diary variables, International Prostate Symptom Scores, and safety and tolerability were assessed.ResultsA total of 172 men (80%) receiving tolterodine ER plus Tamsulosin reported treatment benefit by week 12 compared with 132 patients (62%) receiving placebo (P<.001), 146 (71%) receiving Tamsulosin (P=.06 vs placebo), or 135 (65%) receiving tolterodine ER (P=.48 vs placebo). Patients receiving tolterodine ER plus Tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence (−0.88 vs −0.31, P=.005), urgency episodes without incontinence (−3.33 vs −2.54, P=.03), micturitions per 24 hours (−2.54 vs −1.41, P<.001), and micturitions per night (−0.59 vs −0.39, P.02). Patients receiving tolterodine ER plus Tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score (−8.02 vs placebo, −6.19, P=.003) and QOL item (−1.61 vs −1.17, P=.003). All interventions were well tolerated. The incidence of acute urinary retention requiring catheterization was low (tolterodine ER plus Tamsulosin, 0.4%; tolterodine ER, 0.5%; Tamsulosin, 0%; and placebo, 0%).ConclusionsThese results suggest that treatment with tolterodine ER plus Tamsulosin for 12 weeks provides benefit for men with moderate to severe lower urinary tract symptoms including overactive bladder.Clinical Trials Registrationclinicaltrials.gov Identifier: NCT00147654
Matthias Oelke - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of solifenacin plus Tamsulosin ocas in men with voiding and storage lower urinary tract symptoms results from a phase 2 dose finding study saturn
European Urology, 2013Co-Authors: Philip Van Kerrebroeck, Francois Haab, J C Angulo, Ferenc Katona, Alberto Garciahernandez, Monique Klaver, Klaudia Traudtner, Matthias OelkeAbstract:Abstract Background Storage symptoms are often undertreated in men with lower urinary tract symptoms (LUTS). Objective To evaluate the combination of an antimuscarinic (solifenacin) with an α-blocker (Tamsulosin) versus Tamsulosin alone in the treatment of men with LUTS. Design, setting, and participants A double-blind, 12-wk, phase 2 study in 937 men with LUTS (≥3 mo, total International Prostate Symptom Score [IPSS] ≥13, and maximum urinary flow rate 4.0–15.0ml/s). Intervention Eight treatment groups: Tamsulosin oral controlled absorption system (OCAS) 0.4mg; solifenacin 3, 6, or 9mg; solifenacin 3, 6 or 9mg plus Tamsulosin OCAS 0.4mg; or placebo. Outcome measurements and statistical analysis The primary efficacy end point was change from baseline in total IPSS. Secondary end points included micturition diary and quality-of-life (QoL) parameters. Post hoc subgroup analyses were performed by severity of baseline storage symptoms, with statistical comparisons presented only for Tamsulosin OCAS alone versus combination therapy, due to the small sample size of the solifenacin monotherapy and placebo subgroups. Results and limitations Combination therapy was associated with significant improvements in micturition frequency and voided volume versus Tamsulosin OCAS alone in the total study population; improvements in total IPSS were not significant. Statistically significant improvements in urgency episodes, micturition frequency, total urgency score, voided volume, IPSS storage subscore, IPSS-QoL index, and Patient Perception of Bladder Condition were observed in a subpopulation of men with two or more urgency episodes per 24h (Patient Perception of Intensity of Urgency Scale grade 3 or 4) and eight or more micturitions per 24h at baseline (storage symptoms subgroup) with combination therapy versus Tamsulosin OCAS alone ( p ≤0.05 for the dose–response slope, all variables). Combination therapy was well tolerated, and adverse events were consistent with the safety profiles of both compounds. Conclusions Solifenacin plus Tamsulosin OCAS did not significantly improve IPSS in the total study population but offered significant efficacy and QoL benefits over Tamsulosin OCAS monotherapy in men with both voiding and storage symptoms at baseline. Combination therapy was well tolerated. ClinicalTrials.gov identifier NCT00510406
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monotherapy with tadalafil or Tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international randomised parallel placebo controlled clinical trial
European Urology, 2012Co-Authors: Matthias Oelke, Francois Giuliano, Vincenzo Mirone, Lei Xu, Lars ViktrupAbstract:Abstract Background Tadalafil improved lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH; LUTS/BPH) in clinical studies but has not been evaluated together with an active control in an international clinical study. Objective Assess tadalafil or Tamsulosin versus placebo for LUTS/BPH. Design, setting, and participants A randomised, double-blind, international, placebo-controlled, parallel-group study assessed men ≥45 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥13, and maximum urinary flow rate (Q max ) ≥4 to ≤15ml/s. Following screening and washout, if needed, subjects completed a 4-wk placebo run-in before randomisation to placebo ( n =172), tadalafil 5mg ( n =171), or Tamsulosin 0.4mg ( n =168) once daily for 12 wk. Measurements Outcomes were assessed using analysis of covariance (ANCOVA) or ranked analysis of variance (ANOVA) (continuous variables) and Cochran-Mantel-Haenszel test or Fisher exact test (categorical variables). Results and limitations IPSS significantly improved versus placebo through 12 wk with tadalafil (−2.1; p =0.001; primary efficacy outcome) and Tamsulosin (−1.5; p =0.023) and as early as 1 wk (tadalafil and Tamsulosin both −1.5; p p p p =0.003; Tamsulosin −0.6, p =0.026). The IPSS Quality-of-Life Index and the Treatment Satisfaction Scale–BPH improved significantly versus placebo with tadalafil (both p p >0.1). The International Index of Erectile Function–Erectile Function domain improved versus placebo with tadalafil (4.0; p p =0.699). Q max increased significantly versus placebo with both tadalafil (2.4ml/s; p =0.009) and Tamsulosin (2.2ml/s; p =0.014). Adverse event profiles were consistent with previous reports. This study was limited in not being powered to directly compare tadalafil versus Tamsulosin. Conclusions Monotherapy with tadalafil or Tamsulosin resulted in significant and numerically similar improvements versus placebo in LUTS/BPH and Q max . However, only tadalafil improved erectile dysfunction. Trial registration Clinicaltrials.gov ID NCT00970632
Christopher R. Chapple - One of the best experts on this subject based on the ideXlab platform.
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Pharmacokinetic profile of Tamsulosin OCAS
BJUI, 2006Co-Authors: Christopher R. Chapple, Emmanuel Chartier‐kastlerAbstract:The Tamsulosin oral-controlled absorption system (OCAS®) is a new tablet formulation of the α1-adrenoceptor (α1-AR) antagonist Tamsulosin, which is used for treating lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The tablet uses the OCAS technology, which was specifically designed to give a more continuous 24-h release of Tamsulosin, resulting in a more consistent and continuous 24-h plasma concentration, a lower maximum plasma concentration (Cmax) and an independence of pharmacokinetics (PKs) on food intake. It was expected that the improved PK profile would translate into a better control of day- and night-time symptoms of BPH and a lower risk of adverse events. Phase I PK studies showed that Tamsulosin OCAS indeed has a flattened PK profile with a lower Cmax and a more stable and consistent 24-h concentration of Tamsulosin, independent of food intake, compared to conventional Tamsulosin. A study combining γ-scintigraphy and PK analysis of blood samples confirmed that the improved PK profile of Tamsulosin OCAS is attributed to the tablet being consistently and continuously released throughout the entire gastrointestinal tract, including the colon.
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comparison of the cardiovascular effects of Tamsulosin oral controlled absorption system ocas and alfuzosin prolonged release xl
European Urology, 2006Co-Authors: Martin C. Michel, Christopher R. ChappleAbstract:Abstract Objective The cardiovascular (CV) effects of Tamsulosin oral controlled absorption system (OCAS ® ) 0.4mg were compared with those of alfuzosin prolonged release (XL) 10mg. Methods Two single-dose, crossover studies were performed. In study 1, CV α 1 -adrenoceptor antagonism was assessed by measuring the inhibition of phenylephrine (PE)-induced increases in diastolic blood pressure (DBP) and total peripheral resistance (TPR) before and after dosing with placebo, Tamsulosin OCAS, and alfuzosin XL in 18 young subjects. In study 2, orthostatic stress tests (OTs) were performed before and after dosing with Tamsulosin OCAS and alfuzosin XL in 40 elderly subjects. Pharmacokinetics were assessed in both studies. Results In study 1, Tamsulosin OCAS induced statistically significantly less inhibition of PE-induced increases in DBP at 2h after dosing and in TPR at 2 and 4h after dosing than alfuzosin XL. In study 2, Tamsulosin OCAS had a lower incidence of positive OTs than did alfuzosin XL, with the difference between both treatments being statistically significant at 6h after dosing and for all time points after dosing combined. This was in line with smaller changes in vital signs observed for Tamsulosin OCAS. The t max values for both treatments were comparable. Conclusions Tamsulosin OCAS 0.4mg produces smaller vascular effects than does alfuzosin XL 10mg.
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The effects of Tamsulosin, a high affinity antagonist at functional α1A- and α1D-adrenoceptor subtypes
British Journal of Pharmacology, 1997Co-Authors: A J Noble, Caroline Couldwell, T Uchyiuma, C Korstanje, Russ Chess-williams, K Furukawa, Christopher R. ChappleAbstract:The actions of the α1-adrenoceptor antagonist Tamsulosin have been examined at functional α1-adrenoceptor subtypes and compared with those at the human prostate receptor. At the α1D-adrenoceptors of the rat aorta, Tamsulosin acted as a competitive antagonist with a high affinity (pKB=10.1). At the α1B-adrenoceptor of the rat spleen and rabbit corpus cavernosum penis, Tamsulosin again acted as a competitive antagonist but with a significantly lower affinity (pKB=8.9–9.2). Tamsulosin acted as an unsurmountable antagonist of the α1A-adrenoceptor-mediated responses of the rat and human vas deferens, reducing maximal responses to phenylephrine by 20% and 50%, respectively, at an antagonist concentration of 1 nm. Responses of depolarized (100 mm KCl) rat vas deferens preparations were unaffected by 10 nm Tamsulosin but this concentration reduced maximal responses to 5-hydroxytryptamine (5-HT) in this tissue. When longer antagonist incubation periods (60 min) were used, Tamsulosin behaved as a competitive antagonist on the human prostate with a significantly higher affinity (pKB=10.0) than obtained at the α1B-adrenoceptor. The data demonstrate that Tamsulosin is a high affinity antagonist at functional α1-adrenoceptors with a selectivity α1Dα1A>α1B. In some tissues the compound exhibits an additional unsurmountable antagonist action, the clinical significance of which is unknown. British Journal of Pharmacology (1997) 120, 231–238; doi:10.1038/sj.bjp.0700907
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Tamsulosin the first prostate selective alpha 1a adrenoceptor antagonist a meta analysis of two randomized placebo controlled multicentre studies in patients with benign prostatic obstruction symptomatic bph european Tamsulosin study group
European Urology, 1996Co-Authors: Christopher R. Chapple, Jeanjacques Wyndaele, Jorgen Nordling, F Boeminghaus, A F G V M Ypma, Paul AbramsAbstract:OBJECTIVE: This meta-analysis of two European studies evaluated the efficacy and safety of modified-release Tamsulosin 0.4 mg once daily compared with placebo in patients with benign prostatic enlargement, lower urinary tract symptoms and prostatic obstruction (symptomatic BPH). METHODS: Patients entered a 2-week placebo run-in period, followed by randomization to treatment with Tamsulosin (382 patients) or placebo (193 patients) once daily for 12 weeks. RESULTS: Maximum urinary flow rate improved to a greater extent in the Tamsulosin group (1.6 ml/s, 16%) than the placebo group (0.6 ml/s, 6%) (p = 0.002). Total Boyarsky symptom score also improved to a greater extent in the Tamsulosin group (3.3 points, 35.1% reduction) than the placebo group (2.4 points, 25.5% reduction) (p = 0.002). Significantly more Tamsulosin patients (66%) than placebo patients (49%) had a > or = 25% decrease in total symptom score at endpoint (p < 0.001). Twelve weeks of treatment with Tamsulosin also produced significant improvements in average urinary flow rate (p = 0.005) and voiding or "obstructive" (p = 0.008) and storage or "irritative' (p = 0.017) symptom scores. The incidence of drug-related adverse events was comparable for the Tamsulosin and placebo groups (13 and 12% respectively, p = 0.802). The same applies to the incidence of adverse events commonly attributed to alpha 1-adrenoceptor antagonists, such as dizziness, headache, postural hypotension, syncope, asthenia, somnolence and rhinitis. There were no clinically significant changes in blood pressure or pulse rate in Tamsulosin patients compared with placebo patients both in hypertensive and normotensive BPH patients. CONCLUSION: Tamsulosin 0.4 mg once daily is safe, well-tolerated and improves both the symptoms and urinary flow rate in patients with benign prostatic obstruction (symptomatic BPH).
Claus G Roehrborn - One of the best experts on this subject based on the ideXlab platform.
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the effects of dutasteride or Tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms luts and benign prostatic hyperplasia bph 4 year data from the combination of avodart and Tamsulosin combat stu
BJUI, 2011Co-Authors: Francesco Montorsi, Claus G Roehrborn, Javier Garciapenit, Michael Borre, Ton A Roeleveld, Jean Charles Alimi, Paul Gagnier, Timothy WilsonAbstract:Study Type – Therapy (RCT) Level of Evidence 1b What’s known on the subject? and What does the study add? Long-term treatment with combination therapy (dutasteride plus Tamsulosin) is significantly superior to Tamsulosin but not dutasteride at reducing the relative risk of AUR or BPH-related surgery. Furthermore, combination therapy is significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression, and provides significantly greater reductions in IPSS. In addition, combination therapy significantly improves patient-reported, disease specific QoL and treatment satisfaction compared with either monotherapy. Two-year results from the CombAT study showed that combination therapy was more effective than either monotherapy in controlling both storage and voiding symptoms, irrespective of baseline prostate volume (for men with prostate volume ≥30 cc). This post-hoc two-year analysis also showed that treatment with dutasteride not only improved voiding symptoms, as would be expected from its effects on prostate volume, but was also as effective as the α-blocker Tamsulosin in the control of storage symptoms. OBJECTIVE • To assess the effects of combined therapy with dutasteride and Tamsulosin on voiding and storage symptoms compared with those of dutasteride or Tamsulosin alone, using 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study. PATIENTS AND METHODS • Men (n = 4844) aged ≥50 years with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH), a prostate volume of ≥30 mL, and a serum prostate-specific antigen level of 1.5–10 ng/mL. • CombAT was a multicentre, double-blind, parallel-group study. • Oral dutasteride (0.5 mg) or Tamsulosin (0.4 mg) alone or in combination was taken daily for 4 years. • Mean changes from baseline in storage and voiding symptoms at 4 years were assessed using subscales of the International Prostate Symptom Score. RESULTS • At 4 years, the mean reduction in the storage subscore was significantly greater in the combined therapy group vs the dutasteride (adjusted mean difference −0.43) and Tamsulosin (adjusted mean difference −0.96) monotherapy groups (P < 0.001). • Also at 4 years, the mean reduction in the voiding subscore was significantly greater in the combined therapy group vs the dutasteride (adjusted mean difference −0.51) and Tamsulosin (adjusted mean difference −1.60) monotherapy groups (P < 0.001). • The improvement in the storage subscore with combined therapy was significantly better (P < 0.001) than dutasteride and Tamsulosin from 3 months and 12 months, respectively. Similarly, the improvement in the voiding subscore with combined therapy was significantly better than dutasteride (P < 0.001) and Tamsulosin (P ≤ 0.006) from 3 months and 6 months, respectively. • Improvements in the storage and voiding symptom subscores with combined therapy were achieved irrespective of prostate volume, although in men with the highest baseline prostate volumes (≥58 mL), combined therapy was not better than dutasteride. CONCLUSIONS • In men with a prostate volume of ≥30 mL, combined therapy with dutasteride plus Tamsulosin provided better long-term (up to 4 years) control of both storage and voiding LUTS compared with Tamsulosin monotherapy. • Combined therapy was better than dutasteride monotherapy in men with prostate volumes of ≥30 to <58 mL, but not in men with a prostate volume of ≥58 mL.
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tolterodine extended release with or without Tamsulosin in men with lower urinary tract symptoms including overactive bladder symptoms effects of prostate size
European Urology, 2009Co-Authors: Claus G Roehrborn, Steven A Kaplan, Stephen J Jones, Joseph T Wang, Tamara Bavendam, Zhonghong GuanAbstract:Abstract Background Some men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms may benefit from antimuscarinic therapy, with or without an α-adrenergic antagonist. Objectives To evaluate the safety and efficacy of tolterodine extended release (ER), Tamsulosin, or tolterodine ER+Tamsulosin in men meeting symptom entry criteria for OAB and prostatic enlargement trials, stratified by prostate size. Design, setting, and participants Subjects with an International Prostate Symptom Score (IPSS) ≥12; frequency and urgency, with or without urgency urinary incontinence; postvoid residual volume (PVR) max ) >5mL/s were randomized to receive placebo, tolterodine ER (4mg), Tamsulosin (0.4mg), or tolterodine ER+Tamsulosin for 12 wk. Data were stratified by median baseline prostate volume ( Measurements Endpoints included week 12 changes in bladder diary variables, IPSS scores, and safety variables. Results and limitations Among men with larger prostates, tolterodine ER+Tamsulosin significantly improved frequency ( p =0.001); urgency ( p =0.006); and IPSS total ( p =0.001), storage ( p p p =0.030). Among men with smaller prostates, tolterodine ER significantly improved frequency ( p =0.016), UUI episodes ( p =0.036), and IPSS storage scores ( p =0.005). Tolterodine ER+Tamsulosin significantly improved frequency ( p =0.001) and IPSS storage scores ( p =0.018). Tamsulosin significantly improved nocturnal frequency ( p =0.038) and IPSS voiding ( p =0.036) and total scores ( p =0.044). There were no clinically or statistically significant changes in Q max or PVR; incidence of acute urinary retention (AUR) was low in all groups (≤2%). Conclusions Men with smaller prostates and moderate-to-severe LUTS including OAB symptoms benefited from tolterodine ER. Therapy with tolterodine ER+Tamsulosin was effective regardless of prostate size. Tolterodine ER, with or without Tamsulosin, was well tolerated and not associated with increased incidence of AUR.
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effects of serum psa on efficacy of tolterodine extended release with or without Tamsulosin in men with luts including oab
Urology, 2008Co-Authors: Claus G Roehrborn, Stephen R Kraus, Steven A Kaplan, Joseph T Wang, Tamara Bavendam, Zhonghong GuanAbstract:Objectives To evaluate the efficacy of tolterodine extended release (ER), Tamsulosin, and tolterodine ER plus Tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen (PSA) level. Methods We performed a post hoc analysis of data from men ≥40 years old with frequency and urgency (with or without urge urinary incontinence), postvoid residual urine volume 5 mL/s, International Prostate Symptom Score (IPSS) of ≥12, and quality-of-life score of ≥3. They had been randomized to placebo, tolterodine ER (4 mg), Tamsulosin (0.4 mg), or tolterodine ER plus Tamsulosin for 12 weeks. The men were stratified by the median baseline PSA level (≥1.3 vs Results The PSA level correlated significantly with prostate size. Men with a PSA level of ≥1.3 ng/mL receiving tolterodine ER plus Tamsulosin showed significantly greater improvements in 24-hour frequency, daytime frequency, the frequency-urgency sum, total IPSS, and IPSS storage score compared with those receiving placebo. Tamsulosin significantly improved the IPSS voiding scores, but tolterodine ER was ineffective. In men with a PSA level Conclusions The results of our study have shown that tolterodine ER was efficacious in men with lower urinary tract symptoms, including overactive bladder, who had lower PSA levels (
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extended release tolterodine with or without Tamsulosin in men with lower urinary tract symptoms and overactive bladder effects on urinary symptoms assessed by the international prostate symptom score
BJUI, 2008Co-Authors: Steven A Kaplan, Claus G Roehrborn, Tamara Bavendam, Martin Carlsson, Michael B Chancellor, Zhonghong GuanAbstract:OBJECTIVE To evaluate the efficacy of tolterodine extended-release (ER) plus Tamsulosin on lower urinary tract symptoms (LUTS) as assessed by changes in the International Prostate Symptom Score (IPSS) in men who met symptom entry criteria for both overactive bladder (OAB) and benign prostatic hyperplasia (BPH) trials. PATIENTS AND METHODS Men aged ≥40 years with an IPSS of ≥12 and diary-documented OAB symptoms (≥8 voids/24 h and ≥3 urgency episodes/24 h, with or without urgency urinary incontinence) who reported at least moderate problems related to their bladder condition were randomized to receive placebo, tolterodine ER (4 mg), Tamsulosin (0.4 mg), or tolterodine ER (4 mg) + Tamsulosin (0.4 mg) once daily for 12 weeks. Patients completed the IPSS at baseline and at 1, 6 and 12 weeks. RESULTS Patients receiving tolterodine ER + Tamsulosin had significantly greater improvements than those taking placebo on IPSS storage subscale scores and scores for all three individual storage items included on the IPSS (urinary frequency, urgency, and nocturnal micturitions) by 12 weeks. Storage subscale and urgency scores were significantly improved vs placebo at 1 and 6 weeks, whereas frequency scores were significantly improved at 6 weeks. Changes in IPSS storage subscale and individual storage item scores in the tolterodine ER and Tamsulosin monotherapy groups were not significantly different from placebo at most time points. IPSS voiding subscale scores and scores for three of four individual voiding items (sensation of incomplete emptying, intermittency, and weak stream) were significantly improved by 12 weeks for patients receiving Tamsulosin monotherapy vs placebo. Voiding subscale and intermittency scores were significantly improved vs placebo at 1 week; weak stream scores were significantly improved at 1 and 6 weeks. The IPSS voiding subscale and individual voiding item scores in the tolterodine ER + Tamsulosin and tolterodine ER groups were not significantly different from placebo at most time points. CONCLUSIONS In this distinct clinical research population of men who met traditional symptom entry criteria for both OAB and BPH trials, tolterodine ER + Tamsulosin was significantly more effective than placebo in treating storage LUTS, including OAB symptoms. Tamsulosin monotherapy produced significant improvements in voiding LUTS.
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tolterodine and Tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder a randomized controlled trial
JAMA, 2006Co-Authors: Claus G Roehrborn, Steven A Kaplan, Tamara Bavendam, Eric S Rovner, Martin Carlsson, Zhonghong GuanAbstract:ContextMen with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or α-receptor antagonists.ObjectiveTo evaluate the efficacy and safety of tolterodine extended release (ER), Tamsulosin, or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia.Design, Setting, and ParticipantsRandomized, double-blind, placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and, an International Prostate Symptom Score quality-of-life (QOL) item score of 3 or higher, a self-rated bladder condition of at least moderate bother, and a bladder diary documenting micturition frequency (≥8 micturitions per 24 hours) and urgency (≥3 episodes per 24 hours), with or without urgency urinary incontinence. Patients were recruited between November 2004 and February 2006, and the study was completed May 2006.InterventionsPatients were randomly assigned to receive placebo (n = 222), 4 mg of tolterodine ER (n = 217), 0.4 mg of Tamsulosin (n = 215), or both tolterodine ER plus Tamsulosin (n = 225) for 12 weeks.Main Outcome MeasuresPatient perception of treatment benefit, bladder diary variables, International Prostate Symptom Scores, and safety and tolerability were assessed.ResultsA total of 172 men (80%) receiving tolterodine ER plus Tamsulosin reported treatment benefit by week 12 compared with 132 patients (62%) receiving placebo (P<.001), 146 (71%) receiving Tamsulosin (P=.06 vs placebo), or 135 (65%) receiving tolterodine ER (P=.48 vs placebo). Patients receiving tolterodine ER plus Tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence (−0.88 vs −0.31, P=.005), urgency episodes without incontinence (−3.33 vs −2.54, P=.03), micturitions per 24 hours (−2.54 vs −1.41, P<.001), and micturitions per night (−0.59 vs −0.39, P.02). Patients receiving tolterodine ER plus Tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score (−8.02 vs placebo, −6.19, P=.003) and QOL item (−1.61 vs −1.17, P=.003). All interventions were well tolerated. The incidence of acute urinary retention requiring catheterization was low (tolterodine ER plus Tamsulosin, 0.4%; tolterodine ER, 0.5%; Tamsulosin, 0%; and placebo, 0%).ConclusionsThese results suggest that treatment with tolterodine ER plus Tamsulosin for 12 weeks provides benefit for men with moderate to severe lower urinary tract symptoms including overactive bladder.Clinical Trials Registrationclinicaltrials.gov Identifier: NCT00147654
Steven A Kaplan - One of the best experts on this subject based on the ideXlab platform.
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tolterodine extended release with or without Tamsulosin in men with lower urinary tract symptoms including overactive bladder symptoms effects of prostate size
European Urology, 2009Co-Authors: Claus G Roehrborn, Steven A Kaplan, Stephen J Jones, Joseph T Wang, Tamara Bavendam, Zhonghong GuanAbstract:Abstract Background Some men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms may benefit from antimuscarinic therapy, with or without an α-adrenergic antagonist. Objectives To evaluate the safety and efficacy of tolterodine extended release (ER), Tamsulosin, or tolterodine ER+Tamsulosin in men meeting symptom entry criteria for OAB and prostatic enlargement trials, stratified by prostate size. Design, setting, and participants Subjects with an International Prostate Symptom Score (IPSS) ≥12; frequency and urgency, with or without urgency urinary incontinence; postvoid residual volume (PVR) max ) >5mL/s were randomized to receive placebo, tolterodine ER (4mg), Tamsulosin (0.4mg), or tolterodine ER+Tamsulosin for 12 wk. Data were stratified by median baseline prostate volume ( Measurements Endpoints included week 12 changes in bladder diary variables, IPSS scores, and safety variables. Results and limitations Among men with larger prostates, tolterodine ER+Tamsulosin significantly improved frequency ( p =0.001); urgency ( p =0.006); and IPSS total ( p =0.001), storage ( p p p =0.030). Among men with smaller prostates, tolterodine ER significantly improved frequency ( p =0.016), UUI episodes ( p =0.036), and IPSS storage scores ( p =0.005). Tolterodine ER+Tamsulosin significantly improved frequency ( p =0.001) and IPSS storage scores ( p =0.018). Tamsulosin significantly improved nocturnal frequency ( p =0.038) and IPSS voiding ( p =0.036) and total scores ( p =0.044). There were no clinically or statistically significant changes in Q max or PVR; incidence of acute urinary retention (AUR) was low in all groups (≤2%). Conclusions Men with smaller prostates and moderate-to-severe LUTS including OAB symptoms benefited from tolterodine ER. Therapy with tolterodine ER+Tamsulosin was effective regardless of prostate size. Tolterodine ER, with or without Tamsulosin, was well tolerated and not associated with increased incidence of AUR.
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effects of serum psa on efficacy of tolterodine extended release with or without Tamsulosin in men with luts including oab
Urology, 2008Co-Authors: Claus G Roehrborn, Stephen R Kraus, Steven A Kaplan, Joseph T Wang, Tamara Bavendam, Zhonghong GuanAbstract:Objectives To evaluate the efficacy of tolterodine extended release (ER), Tamsulosin, and tolterodine ER plus Tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen (PSA) level. Methods We performed a post hoc analysis of data from men ≥40 years old with frequency and urgency (with or without urge urinary incontinence), postvoid residual urine volume 5 mL/s, International Prostate Symptom Score (IPSS) of ≥12, and quality-of-life score of ≥3. They had been randomized to placebo, tolterodine ER (4 mg), Tamsulosin (0.4 mg), or tolterodine ER plus Tamsulosin for 12 weeks. The men were stratified by the median baseline PSA level (≥1.3 vs Results The PSA level correlated significantly with prostate size. Men with a PSA level of ≥1.3 ng/mL receiving tolterodine ER plus Tamsulosin showed significantly greater improvements in 24-hour frequency, daytime frequency, the frequency-urgency sum, total IPSS, and IPSS storage score compared with those receiving placebo. Tamsulosin significantly improved the IPSS voiding scores, but tolterodine ER was ineffective. In men with a PSA level Conclusions The results of our study have shown that tolterodine ER was efficacious in men with lower urinary tract symptoms, including overactive bladder, who had lower PSA levels (
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extended release tolterodine with or without Tamsulosin in men with lower urinary tract symptoms and overactive bladder effects on urinary symptoms assessed by the international prostate symptom score
BJUI, 2008Co-Authors: Steven A Kaplan, Claus G Roehrborn, Tamara Bavendam, Martin Carlsson, Michael B Chancellor, Zhonghong GuanAbstract:OBJECTIVE To evaluate the efficacy of tolterodine extended-release (ER) plus Tamsulosin on lower urinary tract symptoms (LUTS) as assessed by changes in the International Prostate Symptom Score (IPSS) in men who met symptom entry criteria for both overactive bladder (OAB) and benign prostatic hyperplasia (BPH) trials. PATIENTS AND METHODS Men aged ≥40 years with an IPSS of ≥12 and diary-documented OAB symptoms (≥8 voids/24 h and ≥3 urgency episodes/24 h, with or without urgency urinary incontinence) who reported at least moderate problems related to their bladder condition were randomized to receive placebo, tolterodine ER (4 mg), Tamsulosin (0.4 mg), or tolterodine ER (4 mg) + Tamsulosin (0.4 mg) once daily for 12 weeks. Patients completed the IPSS at baseline and at 1, 6 and 12 weeks. RESULTS Patients receiving tolterodine ER + Tamsulosin had significantly greater improvements than those taking placebo on IPSS storage subscale scores and scores for all three individual storage items included on the IPSS (urinary frequency, urgency, and nocturnal micturitions) by 12 weeks. Storage subscale and urgency scores were significantly improved vs placebo at 1 and 6 weeks, whereas frequency scores were significantly improved at 6 weeks. Changes in IPSS storage subscale and individual storage item scores in the tolterodine ER and Tamsulosin monotherapy groups were not significantly different from placebo at most time points. IPSS voiding subscale scores and scores for three of four individual voiding items (sensation of incomplete emptying, intermittency, and weak stream) were significantly improved by 12 weeks for patients receiving Tamsulosin monotherapy vs placebo. Voiding subscale and intermittency scores were significantly improved vs placebo at 1 week; weak stream scores were significantly improved at 1 and 6 weeks. The IPSS voiding subscale and individual voiding item scores in the tolterodine ER + Tamsulosin and tolterodine ER groups were not significantly different from placebo at most time points. CONCLUSIONS In this distinct clinical research population of men who met traditional symptom entry criteria for both OAB and BPH trials, tolterodine ER + Tamsulosin was significantly more effective than placebo in treating storage LUTS, including OAB symptoms. Tamsulosin monotherapy produced significant improvements in voiding LUTS.
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tolterodine and Tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder a randomized controlled trial
JAMA, 2006Co-Authors: Claus G Roehrborn, Steven A Kaplan, Tamara Bavendam, Eric S Rovner, Martin Carlsson, Zhonghong GuanAbstract:ContextMen with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or α-receptor antagonists.ObjectiveTo evaluate the efficacy and safety of tolterodine extended release (ER), Tamsulosin, or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia.Design, Setting, and ParticipantsRandomized, double-blind, placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and, an International Prostate Symptom Score quality-of-life (QOL) item score of 3 or higher, a self-rated bladder condition of at least moderate bother, and a bladder diary documenting micturition frequency (≥8 micturitions per 24 hours) and urgency (≥3 episodes per 24 hours), with or without urgency urinary incontinence. Patients were recruited between November 2004 and February 2006, and the study was completed May 2006.InterventionsPatients were randomly assigned to receive placebo (n = 222), 4 mg of tolterodine ER (n = 217), 0.4 mg of Tamsulosin (n = 215), or both tolterodine ER plus Tamsulosin (n = 225) for 12 weeks.Main Outcome MeasuresPatient perception of treatment benefit, bladder diary variables, International Prostate Symptom Scores, and safety and tolerability were assessed.ResultsA total of 172 men (80%) receiving tolterodine ER plus Tamsulosin reported treatment benefit by week 12 compared with 132 patients (62%) receiving placebo (P<.001), 146 (71%) receiving Tamsulosin (P=.06 vs placebo), or 135 (65%) receiving tolterodine ER (P=.48 vs placebo). Patients receiving tolterodine ER plus Tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence (−0.88 vs −0.31, P=.005), urgency episodes without incontinence (−3.33 vs −2.54, P=.03), micturitions per 24 hours (−2.54 vs −1.41, P<.001), and micturitions per night (−0.59 vs −0.39, P.02). Patients receiving tolterodine ER plus Tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score (−8.02 vs placebo, −6.19, P=.003) and QOL item (−1.61 vs −1.17, P=.003). All interventions were well tolerated. The incidence of acute urinary retention requiring catheterization was low (tolterodine ER plus Tamsulosin, 0.4%; tolterodine ER, 0.5%; Tamsulosin, 0%; and placebo, 0%).ConclusionsThese results suggest that treatment with tolterodine ER plus Tamsulosin for 12 weeks provides benefit for men with moderate to severe lower urinary tract symptoms including overactive bladder.Clinical Trials Registrationclinicaltrials.gov Identifier: NCT00147654
